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FDA 510(k) Application Details - K150217
Device Classification Name
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device
510(K) Number
K150217
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
Sirona Dental Systems GMBH
Fabrikstrasse 31
Bensheim 64623 DE
Other 510(k) Applications for this Company
Contact
Thomas Diesch
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
OAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2015
Decision Date
05/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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